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Interesante este documento de IMDRF como siempre, incluye:
– Principles for Medical Device and IVD Medical Device Identification
– General Labeling Principles for Medical Devices and IVD Medical Devices. Labeling, Label, Instructions for Use
– General Labeling Principles for Medical Devices other than IVD Medical Devices. Labeling, Label, Instructions for Use
– General Labeling Principles for IVD Medical Devices. Labeling, Label, Instructions for Use
– Labeling Principles for Medical Devices Containing Software or Software as a Medical Device
– Labeling Principles for Medical Devices and IVD Medical Devices Intended for Use by Lay Persons
– Labeling Principles for Information Intended for the Patient.